Vivasure Medical has recruited the first patients in its study of the PerQseal closure device system, which is designed for arteriotomies.
The PATCH clinical study, which is a multi-centre, single-arm, pivotal trial, will assess the system’s safety and efficacy.
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Dr Vijay Iyer, University of Buffalo cardiology chief and Buffalo General Hospital structural heart interventions director enrolled the initial patients for the trials at Kaleida Health’s Buffalo General Medical Center-Gates Vascular Institute, located in Buffalo, New York.
In a statement, Dr Iyer said: “Large bore closure can be challenging and PerQseal is a promising technology for interventional cardiologists as a growing number of treatment options for patients utilise fully percutaneous approaches.”
The pivotal trial aims to recruit a maximum of 171 patients in the US, along with up to 90 patients at up to eight investigational sites in Europe.
The results of the study will be utilised for a pre-market approval submission to the US Food and Drug Administration (FDA).
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By GlobalDataPerQseal is claimed to be the first sutureless and fully absorbable synthetic implant for the closure of large-bore arterial vessel punctures.
Deploying the device from inside the vessel offers a simpler and more controlled approach compared to conventional closure techniques.
PerQseal PATCH study principal investigator Dr William Gray said: “With the recent proliferation of large bore arterial access, there’s a moment at the completion of each procedure when vessel management is critical and clinicians must quickly and effectively close it to reduce unnecessary, potentially life-threatening bleeding.
“I look forward to evaluating the PerQseal technology and its simplified, controlled technique – with the ultimate goal of reducing vascular complications for these patients.”
